Recall Z-0083-2018 ยท FZP Clip, Implantable
Teleflex Medical
WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
| Date | Oct 5, 2017 |
| Status | Terminated |
| Reason | The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. |
| Root cause | Under Investigation by firm |
| Action | The firm initiated their recall on 05 OCT 2017 via FedEx 2-day. The letter requested the following actions to be taken by hospitals to remove product from the facilities: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will c |
| Quantity | 13,710 units |
| Distribution | Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152081 | Weck Auto Endo5 Hem-o-lok Ligating Clip Applier Teleflexmedical, Inc., Aug 26, 2015 |